Speaker & co-chairs

Tucker A. Patterson, Ph.D. is Center Director at the FDA’s National Center for Toxicological Research (NCTR). Dr. Patterson previously served as the Deputy Director for Research in the Office of the Center Director/Office of Research. Prior to this appointment, he served two years as the Associate Director for Science & Policy and over seven years as the Associate Director and Health Science Program Manager in Regulatory Compliance & Risk Management at NCTR. Dr. Patterson received a B.S. in Chemistry from the University of Arkansas at Fayetteville and a Ph.D. in Pharmacology from the University of South Carolina. He completed a two-year postdoctoral fellowship with the Center for the Neurobiology of Aging at the University of Florida and continued his postdoctoral training at NCTR through a postgraduate research appointment with the Oak Ridge Institute for Science and Education and as a staff fellow. Dr. Patterson has been involved in neuroscience and neurotoxicology research for more than thirty years and has authored or co-authored over 100 peer-reviewed scientific articles and book chapters.   read more...   read less

Dr. Weida Tong is the Chair of Global Coalition of Regulatory Science Research (GCSRS). He is working at FDA's National Center for Toxicological Research (NCTR) as a division director for Bioinformatics and Biostatistics.

Michael Renaudin studied social anthropology and later sociology at the University of Bern. He subsequently completed a postgraduate degree in Digital Leadership and earned an MBA. After working in IT, project management and adult education – in both the private and public sectors – he has been with Swissmedic for fifteen years and will remain there until the end of September 2025. Initially responsible for organisational learning and staff development, he is now the head of Swissmedic 4.0, the innovation lab of Swissmedic. In this role, Michael Renaudin is responsible for leading the digital initiative as well as for the areas of strategy, innovation and information communication.   read more...   read less

Philipp Weyermann is a team leader in the Regulatory Assessment division at Swissmedic, the Swiss therapeutic products agency. His role includes responsibility for substance management and the substance database. Philipp is a long time member in several international standardisation bodies, including the Global Identification of Medicinal Products (IDMP) Working Group (GIDWG) and the IDMP Working Group under the International Pharmaceutical Regulators Programme (IPRF). He is a chemist by training with a Msc from the University of Berne and a PhD from ETH Zurich as well as a Postdoc at Caltech. Before joining Swissmedic in 2010 he worked in the pharmaceutical industry as a medicinal chemist and project leader.   read more...   read less

PDr. Elisabeth Klenke joined Swissmedic in 2006 as a preclinical reviewer and GLP inspector. Prior to this, she held positions as a study director at a contract research organization (CRO), overseeing toxicological studies, and worked in the field of regulatory affairs. She has been a registered European Toxicologist (ERT) since 2007. Since 2011, she has served as Head of the Division for Nonclinical Assessment and the GLP Inspectorate and was appointed Vice Chair of the International Medicines Regulators’ Working Group on 3Rs (IMRWG3Rs) in 2024.   read more...   read less

Angela Bearth holds a degree in Social and Health Psychology from the University of Zurich and a PhD in Risk Research. For ten years, she worked in the Consumer Behavior group at the Federal Institute of Technology (ETH Zurich). She is founder and CEO of the private research company HF Partners and is currently employed as the senior social scientist at the Swiss Centre for Applied Human Toxicology at the University of Basel. Over the years, she has initiated several projects focused on chemical and technological risks, stakeholder engagement, and risk communication. She is a member of the Scientific Committee of the European Food Safety Authority and the president of the Society for Risk Analysis Europe.   read more...   read less

B.Sc. Pharmacy, University of Strathclyde (1979) and Ph.D. Pharmaceutics, University of London (1984). Fellow of AAPS, CRS, APSTJ, AIMBE and NAI. 2010 CRS President; 2002 AAPS President. Editor of IJP (2009 – 2018). Editorial board 14 international journals. 2024 NIPTE Grant Distinguished Scholar; 2023 AAPS Advancement of Women in Pharmaceutical Sciences; 2023 UConn AAUP Marth Mentorship Award; 2018 AAPS Wurster Award; 2014 AAPS Research Achievement Award; 2014 AAPS Outstanding Educator Award; 2014 CRS Distinguished Service Award; 2013 AAPS IPEC Shangraw Award; 2010 CRSI Fellowship, 2011 APSTJ Nagai Woman Scientist Award. 309 refereed publications 770 research presentations, 362 invited presentations, 30 keynote/plenary addresses. 15 patents, 12 licensed and 8 products commercialized. Founder, DIANT Pharma (2019). DIANT develops continuous manufacturing technology for nanoparticles.   read more...   read less

Claudius Griesinger has been working for the European Commission’s Joint Research Centre (JRC) since 2006. He worked on biomedical testing methods, contributing to OECD guidelines and coordinating expert advice and stakeholder dialogue. From 2015 to 2022 he was responsible for the JRC’s contribution to the implementation of the EU’s medical devices/in vitro diagnostics regulations, focusing on signal detection, emerging technologies including artificial intelligence (AI) and setting up expert panels on high-risk devices, now managed by EMA. Since 2022 he is member of the leadership team of the JRC’s project portfolio on “Innovation in Life and Health Sciences”, with his team focusing on AI in healthcare & medicine and innovative cancer treatments. Claudius has a neurosciences degree from the University of Tübingen. His PhD at Max Planck Institute for Developmental Biology was about molecular mechanisms of neural network development in visual cortex. As a postdoc at University College London he worked on ultrafast synaptic transmission. Before joining the EC, Claudius was an assistant professor for physiology at University of Freiburg.   read more...   read less

Dr. Calzolai has a MS (University of Florence) and PhD (University of Siena) in chemistry. After a Postgraduate Research at the University of California, Davis, he joined, in 1998, the Swiss Institute of Technology in Zurich, in the laboratory of the then Nobel laureate Kurth Wuthrich, where he determined the three dimensional structure of prion proteins responsible of neurological disorders, such as Mad Cow Disease. In 2007, he moved to the University of Kent (UK) as Senior Lecturer in biochemistry. In 2008, he joined the Joint Research Centre of the European Commission where his research focuses on the development of methods for the characterization of nanomedicines (in particular RNA-based) and biotherapeutics. He is an expert in the European Pharmacopeia working group on mRNA vaccines.   read more...   read less

Irene Cattaneo is a Scientific Officer at the European Food Safety Authority (EFSA), in the Methodology and Scientific Support (MESE) Unit. Irene graduated in Pharmaceutical Chemistry and Technology at the University of Milan (Italy) and did her thesis on Neurotoxicology. She is involved in several scientific activities relating to EFSA’s Scientific Committee in the area of chemical risk assessment. She is currently coordinating the EFSA Working Group on Particle Risk Assessment - subgroup Advice, and she is also involved in other activities and projects related to Nanotechnologies and/or New Approach Methodologies for the risk assessment at EFSA.   read more...   read less

In 2022, Dr. Tammy Collins joined the Burroughs Wellcome Fund (BWF), a nonprofit philanthropic organization whose mission is to improve human health. At BWF, Dr. Collins serves as a Program Officer where she directs the Career Awards at the Scientific Interface (CASI) program and the Innovations in Regulatory Science Awards (IRSA). She serves on the US National Academies of Science, Engineering, and Medicine’s (NASEM) Forum on Drug Discovery, Development, & Translation as well as NASEM’s Forum on Regenerative Medicine. Prior to joining BWF, Dr. Collins served as Training Director at the National Institutes of Health | National Institute of Environmental Health Sciences (NIH | NIEHS) and was Chair-elect of the NIH-wide Training Directors’ Committee. At NIEHS, Dr. Collins made career outcomes of postdoctoral scholars transparent (see Nature Biotechnology publication). Dr. Collins received her bachelor’s in chemistry from Appalachian State University (ASU), and her Ph.D. in biochemistry from Duke University. After a brief postdoc at Duke, she joined NIEHS as a postdoc in 2009 where she developed her passion for helping foster scientific leaders.   read more...   read less

With close to 25 years of leadership experience in all phases of drug and vaccine development, I have been privileged to live and work around the world, developing a global mindset as well as a flexible and creative approach to problem solving. My experience is cross-functional (Discovery, CMC, Clinical development and operation, regulatory science) and cross-sectorial in both Pharm and Medical Devices. Throughout my career, I have strived to establish strong and fit-for-purpose collaborations with a broad spectrum of partners in the field of public health to help solve some of the most challenging un-meet medical needs, including global pandemics. Being a curious and daring leader, I have recently emphasized development in the field of Health data, AI, RWE and the European Health Data Space framework, by taking a leading role in European Commission-funded Public-Private-Partnership program. From November 2023, I joined the European Medicines Agency, where I lead the Task Force on Regulatory Science and Innovation.   read more...   read less

Thomas Hartung, MD PhD, is the Doerenkamp-Zbinden-Chair for Evidence-based Toxicology in the Department of Environmental Health and Engineering at Johns Hopkins Bloomberg School of Public Health, Baltimore, with a joint appointment at the Whiting School of Engineering. He also holds a joint appointment for Molecular Microbiology and Immunology at the Bloomberg School. He is adjunct affiliate professor at Georgetown University, Washington D.C.. In addition, he holds a joint appointment as Professor for Pharmacology and Toxicology at University of Konstanz, Germany; he also is Director of Centers for Alternatives to Animal Testing (CAAT, http://caat.jhsph.edu) of both universities. CAAT hosts the secretariat of the Evidence-based Toxicology Collaboration (http://www.ebtox.org), the Good Read-Across Practice Collaboration, the Good Cell Culture Practice Collaboration, the Green Toxicology Collaboration and the Industry Refinement Working Group. As PI, he headed the Human Toxome project funded as an NIH Transformative Research Grant. He is Chief Editor of Frontiers in Artificial Intelligence. He is the former Head of the European Commission’s Center for the Validation of Alternative Methods (ECVAM), Ispra, Italy, and has authored more than 600 scientific publications (h-index 100).   read more...   read less

Cesare Furlanello is an expert in Machine Learning, predictive models, and reproducibility of AI; since June 2023, he is Director of the "Lifescience Innovation Good Healthcare Technology -LIGHT" Center in Brescia, Italy. Former Director of Data Science and Head of the Predictive Models for Biomedical & Environmental Data research Unit at Fondazione Bruno Kessler - FBK (Trento, Italy). National habilitation as full professor in Biomedical Engineering. Adjunct faculty at Wistar Institute (Philadelphia, USA). Editorial board member of Nature Scientific Data and British Journal of Clinical Pharmacology. AI and Bioinformatics collaborator within the MAQC/SEQC initiative, and of the FANTOM5 consortium. Formerly, President of the international Massive Analysis and Quality Control (MAQC) Society. He is a founder at HK3 Lab and Orobix Life, AI startups for Predictive Health.   read more...   read less

Cesare Furlanello is an expert in Machine Learning, predictive models, and reproducibility of AI; since June 2023, he is Director of the "Lifescience Innovation Good Healthcare Technology -LIGHT" Center in Brescia, Italy. Former Director of Data Science and Head of the Predictive Models for Biomedical & Environmental Data research Unit at Fondazione Bruno Kessler - FBK (Trento, Italy). National habilitation as full professor in Biomedical Engineering. Adjunct faculty at Wistar Institute (Philadelphia, USA). Editorial board member of Nature Scientific Data and British Journal of Clinical Pharmacology. AI and Bioinformatics collaborator within the MAQC/SEQC initiative, and of the FANTOM5 consortium. Formerly, President of the international Massive Analysis and Quality Control (MAQC) Society. He is a founder at HK3 Lab and Orobix Life, AI startups for Predictive Health.   read more...   read less

Mar Gonzalez joined the Organisation for Economic Co-operation and Development (OECD) in 2004. Throughout her tenure, she has taken on numerous responsibilities related to safety and risk assessment, as well as the international harmonisation of regulations concerning chemicals and modern biotechnology products. Her involvement spans various technical programmes, including biosafety, the safety of novel foods and feeds, chemical accident prevention, preparedness and response, nanomaterials, and the development of test guidelines for chemical safety assessment. Mar Gonzalez coordinates the implementation the OECD programme on nanomaterials and advanced materials, which focuses on developing tools for assessing the hazards of nanomaterials and, more recently, on ensuring the safety of next-generation materials.   read more...   read less

Andrea Haase studied biochemistry at the University of Tübingen, obtained a PhD from the University of Heidelberg, finished a postgraduate study in Toxicology at the University of Leipzig and completed her habilitation in pharmacology and toxicology at the Freie Universität Berlin. Since 2008 she is working at the German Federal Institute for Risk Assessment (BfR) in Berlin, where she is the Unit Head of the “Fibre and Nanotoxicology” Unit and the Deputy Department Head of the “Chemical and Product Safety” department. Her research is strongly focused on New Approach Methodologies (NAMs) and their application for human health risk assessments as well as for Safe-and-Sustainable-Innovation Approaches (SSIA). She has written more than 100 scientific publications and is involved in several large research projects such as GRACIOUS, NanoInformaTIX, HARMLESS, POLYRISK, NAMs4NANO. Furthermore, she is a national scientific expert in the EFSA Nano Network (Network for Risk Assessment of Nanotechnologies in Food and Feed) since 2024.   read more...   read less

Dr. Yuki Haraya is Section Chief in the Department of Biochemistry at the National Institute of Health Sciences (NIHS), Japan. He earned his Ph.D. in Pharmaceutical Sciences from Tokushima University (Japan) in 2015. His career has included roles as Assistant Professor at Himeji Dokkyo University, Research Scientist and Senior Scientist at NIHS, and Uehara Memorial Foundation Research Fellow at the U.S. National Institutes of Health, where he also served as Visiting Researcher at American University. He currently leads regulatory science research using advanced microscopy techniques such as AFM and cryo-EM to characterize nanomedicines including lipid-based drug delivery systems. He is a member of the IPRP Nanomedicines Working Group.   read more...   read less

Alexander Horst, Data Scientist at veanu, works alongside a dedicated team to support the shift from black-box AI systems to transparent, open-source tools for regulatory use. Drawing on his experience at a regulatory body and his background in digital health, he brings a perspective that connects technical development with practical policy needs. At GSRS25, Alexander will share Veanu's vision in a talk titled “From Closed Source to Open Source – Why Transparency is the Future of Regulatory AI.” The presentation will explore how collaborative efforts like FraudCrawler, an open prototype for detecting anomalies in regulatory data, can foster trust, support shared evaluation methods, and enable scalable innovation across agencies. Rather than a challenge, open source is presented as a foundation for building reliable, equitable, and globally relevant AI systems in health and regulation.   read more...   read less

Dr. Johnston’s has over 20 years experience in the formulation of liposomes and lipid nanoparticles (LNP) and is a research scientist within Health Canada. He and his laboratory’s current focus is on the development of model LNP vaccines as a tool for regulatory improvement of these products. Dr. Johnston also heads the Health Products and Food Branches nanotechnology working group, previously co-chaired the International Pharmaceutical Regulators Forum Nanomecidines working group and is a member of the Government of Canada’s Interdepartmental Nanotechnology working group.   read more...   read less

Predrag Kukic earned his PhD specialising in the application of AI to protein structure prediction. Previously, he worked on target identification projects for neurodegenerative diseases. Since 2017, he has been part of the multidisciplinary scientific team at SERS, Unilever, which plays a key role in ensuring that Unilever’s innovations are designed to be both safe and environmentally sustainable, without relying on animal testing. Predrag currently leads capability development in the Human Systemic area at SERS and provides expert scientific input to safety assessment projects in structural biology, bioinformatics, and broader computational toxicology.   read more...   read less

Gro Haarklou Mathisen is a Senior Advisor at the Norwegian Scientific Committee for Food and Environment. She is a risk assessor and methodologist and leads health risk assessments of chemical substances in foods and personal care products. Current research interests include implementation of systematic review principles and methods in chemical risk assessments and also the development of such methods for new approach methodologies (NAMs). She leads a PARC project focusing on the creation of validity assessment tools for in vitro studies. She is also the project lead for the “Collaboration to Harmonise the Assessment of Next Generation Evidence” (CHANGE) project. She graduated in Toxicology from the University of Oslo and obtained a PhD from the School of Pharmacy at the University of Oslo.   read more...   read less

Dr Caterina Minelli, Science Area Leader, leads NPL’s metrology research for development and manufacturing of nanomedicines. A nuclear physicist by training, Caterina obtained a PhD in Nanotechnology from the Ecole Polytechnique Fédérale de Lausanne (Switzerland) and subsequently worked on engineered biomaterials at the National Institute for Materials Science of Japan and Imperial College London in UK. Since 2010, Caterina works at NPL, where she drives nanoparticle international standardisation efforts and acts as an expert in technical committees including ISO TC229 (Nanotechnologies), and the NANO Working Party of the European Directorate for the Quality of Medicines and Healthcare. Caterina is Chartered Physicist and a Fellow of the Institute of Physics.   read more...   read less

Dr. Tadahaya Mizuno is an Assistant Professor at the Graduate School of Pharmaceutical Sciences, The University of Tokyo. He also holds a cross-appointment at the Institute of Statistical Mathematics, Research Organization of Information and Systems (from July 2025). He earned his Ph.D. in Pharmaceutical Sciences from the University of Tokyo in 2014, where he conducted mechanistic studies on membrane transporters. His current research lies at the intersection of pharmaceutical sciences and bioinformatics. He focuses on pattern recognition in life science data, aiming to extract latent representations from diverse data types such as omics profiles, chemical structures, and toxicopathological images. His work contributes to a deeper understanding of drug actions and data-driven prediction of toxicological responses. Dr. Mizuno has received several early-career awards, including the Encouragement Award from the Japanese Society of Toxicology (2025), the Young Scientists Award from the Pharmaceutical Society of Japan (2024), and the Young Investigator Award from the Chemical and Biological Informatics Society (2024). He has also been invited to speak at major national and international conferences, including the 26th North American ISSX and 39th JSSX Joint Meeting. His representative publications appear in journals such as Nature Communications, Briefings in Bioinformatics, Toxicological Sciences, and Journal of Cheminformatics.   read more...   read less

Nicolas Löffler-Perez, Ph.D., Data Scientist at Swissmedic has broad experience with ML methods in the clinic and in regulatory science. At Swissmedic, he has developed tools to crawl information from e-commerce websites in the search for illegal medicines or medical devices, he has developed internal search engines using AI as well as surveying tools using complex algorithms to sample the Swissmedic expert opinion. Dr. Löffler-Perez has contributed to Swissmedic in many forms developing and integrating into production the technology of the future and has shared extensively in conferences what Swissmedic as an organizations has learnt along the way. In his talk “Cutting Edge Technology in Regulatory Science – who is doing what? A landscape view of new technologies worldwide” Dr. Löffler-Perez will go over a general overview about what is being done from different agencies to digitalize and automate their work.   read more...   read less

Dr. Xingchao Geng received his bachelor and master degree from Peking University Health Science Center (Beijing, China) and Ph.D in pharmacology at The Fourth Military Medical University in China. He joined the National Center for Safety Evaluation of Drugs (NCSED), National Institutes for Food and Drug Control (NIFDC) for Toxicological Research to develop toxicological methods for safety evaluation of novel drugs in 2004. Currently, Xingchao Geng is director of IPBC/NIFDC. He is excellent in pharmacology and new compound researching and discovery. He has more than twenty years experience in drugs screening and studying, especially in safety evaluation of drugs and has performed about 200 non-clinical drug safety assessment studies according to GLP regulations including 20 international studies from USA and France. He specializes in the research of new Biomarkers, immunotoxicity and hepatotoxicity research. He has published more than 100 papers and book chapters, and has been invited to present in national and international conferences. AS a visiting scholar, He worked and was trained in Huntingdon life Sciences company in United Kingdom, National Toxicology Research Center (NCTR) of US FDA, the United States Environmental Protection Agency (EPA) and National Institute of Environmental Health Sciences (NIEHS), et al.   read more...   read less

Dr. Douglas GILLILAND received his Ph.D in applied chemistry from the University of Strathclyde, Glasgow in 1993. After 3 year period as post-doctoral research fellow within the JRC Institute for Advanced Materials of, he became an official of the European commission in 1997. Within JRC he gained research experience in studies of corrosion, developed analytical applications of radiotracers and has specialized in surface analytical chemistry by XPS and ToF-SIMS. More recently he has been developing methods for the wet chemical synthesis, detection and physicochemical characterization of nanostructured materials and nanoparticles. Since the end of 2013 he has been a group leader with responsibility for scientific activities relating to nanoparticles detection and characterisation. Currently he is contributing to the development of new research activities relating to the analytics of micro and nanoplastics.   read more...   read less

Professor Carlos Gonçalo das Neves, a Portuguese and Norwegian citizen, graduated in Veterinary Medicine, from the Technical University of Lisbon in 2004, and obtained his PhD in veterinary science in 2009 from the Norwegian School of Veterinary Sciences. He holds also a Postgraduate Certificate in Public Health from the London School of Hygiene and Tropical Medicine, and a Certificate in Public Policy from the London School of Economics. He is the Chief Scientist of the European Food Safety Authority, having served previously between 2019 and 2022 as the Director of Research and Internationalization of the Norwegian Veterinary Institute (NVI), and between 2014 and 2017 as head of virology and head of food safety and emerging threats at the same institution. He holds a joint position as Full Professor at the Faculty of Medical Sciences at the University of Tromsø. Prof. das Neves has worked in the field of wildlife diseases, and has experience on topics related to ONE HEALTH, emerging threats, wildlife health and food safety and systems. He has a strong background in science to policy translation, advocacy and societal awareness. In 2013 he obtained the diploma of specialist of the European College of Zoological Medicine, and is currently the chair of the Wildlife Population Health Speciality. Between 2014-2018 we served also as an expert in animal welfare and health for the Norwegian Scientific Committee for Food and the Environment. He is a Commissioner of the Lancet ONE HEALTH Commission, and a member of the Global 1 Health Network and of the One Sustainable Health Forum, as well as a lead author on the ongoing IPBES Nexus assessment on the interlinkages among biodiversity, water, food and health. He is a Member of the IUCN Wildlife Health Specialist Group, and has served between 2019 and 2021 as the President of the Wildlife Disease Association. He has also served as Honorary Consul of Portugal in Norway between 2010 and 2017.   read more...   read less

PGrzegorz (Greg) Podrygajlo, PhD, Director and Head of Global Manufacturing Site Support, Regulatory Affairs CMC for Biologics at CSL. With a background in Medical Biotechnology and a PhD in Neuroscience, Greg brings deep expertise in technical CMC, GMP, ICH, and generative AI. He leads global regulatory strategy across four manufacturing sites, driving integration of Regulatory Information Management Systems with next-gen Quality Management Systems. Greg collaborates cross-functionally on strategic initiatives including digital transformation, automation, and new facility design to enhance regulatory efficiency and compliance.   read more...   read less

Dr. Hubert Rauscher (PhD in Physics, Technical University Munich, Lecturer in Physical Chemistry, University Ulm, Germany) is working for the European Commission’s (EC) Joint Research Centre (JRC) on nanomaterials and nanosafety and related regulatory questions since 2005. Previously he carried out research on physico-chemical properties of nanostructures and nanoparticles at the University of Wisconsin-Madison (USA) and at the University Ulm (Germany). Hubert is team leader for Advanced Materials Governance at the JRC and leads the activities on the EC's nanomaterial definition and its regulatory implementation, provides scientific support to make EU legislation fit for Advanced Materials including nanomaterials and works with international fora such as the OECD’s Working Party on Manufactured Nanomaterials. Recent activities focus on policy support and regulatory needs for Advanced Materials. Hubert is co-developer of the EC/JRC Framework for Safe and Sustainable by Design (SSbD) Chemicals and Materials.   read more...   read less

Lixian Schmid, Ph.D., Automation/AI Projects Lead and Subject Matter Expert in Global Regulatory Affairs CMC at CSL. Lixian is a seasoned expert at the forefront of advanced technologies in regulatory science. With nearly two decades of experience at the intersection of information technology and life sciences, she has led numerous initiatives that leverage automation and artificial intelligence to streamline regulatory processes and enhance compliance within the complex CMC landscape.

Philippe Schwaller received a bachelor’s and master’s degree from EPFL. While working for IBM Research, Philippe completed an MPhil degree at the University of Cambridge and a PhD in Chemistry and Molecular Sciences with the Reymond group at the University of Bern. In February 2022, Philippe joined EPFL as a tenure-track assistant professor at the Institute of Chemical Sciences and Engineering. He leads the Laboratory of Artificial Chemical Intelligence (LIAC), which works on AI-accelerated discovery and synthesis of molecules. Philippe is a core PI of the NCCR Catalysis, a Swiss centre for sustainable chemistry research, education, and innovation.   read more...   read less

Dr. Leming Shi is a professor at the School of Life Sciences and Shanghai Cancer Center of Fudan University in Shanghai, China. Dr. Shi’s research aims to improve the success rate of drug discovery and development and to promote precision medicine by generating, analyzing, and integrating high-quality multiomics data. Dr. Shi conceived and led the MicroArray and Sequencing Quality Control (MAQC/SEQC) consortia, publishing five special issues in Nature Biotechnology (NBT). These efforts led to the development of multiple FDA guidance documents and the launch of the International MAQC Society (www.maqcsociety.org) to enhance the reproducibility of high-throughput technologies. Dr. Shi was a co-founder of Chipscreen Biosciences (Shanghai Stock Exchange: 688321.SH), where he co-developed a chemogenomics-based drug discovery platform, leading to the marketing approvals of one novel HDAC inhibitor for treating cancers (Chidamide, China 2014 and Japan 2021) and one novel PPARα/γ/δ pan-agonist (Chiglitazar, China 2021) for treating type 2 diabetes. Dr. Shi and his collaborators developed a multiomics-based approach for molecular subtyping and precision treatment of breast cancers, significantly improving patient survival (Cancer Cell 2019; Nature Genetics 2023; and Nature Cancer 2024). Dr. Shi’s team recently developed the first suite of certified multiomics reference materials including matched DNA, RNA, proteins, and metabolites from the same Chinese Quartet cell lines (chinese-quartet.org), which allowed for the development of the sample-to-reference ratio (SRR)-based multiomics quantification approach that is inherently more resistant to batch effects and more suitable for data integration (NBT 2024a and 2024b). Dr. Shi has published over 200 peer-reviewed papers with >20,000 citations in SCI-indexed journals and an h-index of 70. He has (co-)led the development of four ISO and CLSI standards and guidance documents on genomics.   read more...   read less

Henric Taavola‑Gustafsson is a Senior Data Scientist at the Uppsala Monitoring Centre, specializing in pharmacovigilance where he blends rigorous data science and computational methods aiming to make medicines safer. With a master’s in Space Engineering from Luleå University of Technology and a PhD in Astroparticle Physics from Uppsala University, Henric brings a unique interdisciplinary perspective to the pharmacovigilance field. An avid technologist, describing his passion for technology as “if it has a battery or a power cord, I’m probably interested”, Henric has dedicated his career to exploring how advanced methodology, especially generative artificial intelligence, can be responsibly harnessed in medicine. His work focuses on applying these advanced methods while ensuring compliance with safety, efficacy, and ethical standards.   read more...   read less

Alexander Tropsha, PhD. is K.H. Lee Distinguished Professor at the UNC Eshelman School of Pharmacy, UNC-Chapel Hill and Chief Domain Scientist for Molecular Informatics at the Renaissance Computing Institute (RENCI). He is also an Adjunct Professor at the Department of Biomedical Engineering, Department of Computer Science, Department of Applied Physical Sciences, and School of Data Science and Society at UNC. Prof. Tropsha obtained his PhD in Chemical Enzymology in 1986 from Moscow State University, Russia. His research interests are in the areas of Computer-Assisted Drug Design, Cheminformatics, Computational Toxicology, Materials Informatics, Structural Bioinformatics, and Biomedical Knowledge Graph Mining. He has authored or co-authored over 300 peer-reviewed research papers, reviews, and book chapters. His research has been supported by multiple grants from the NIH, NSF, EPA, DOD, research foundations, and private companies. He is an elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and a consultant to several technology and drug discovery companies. In 2019, he co-founded a UNC startup, Predictive, LLC, focusing on the development of computational tools for assessing safety of drug molecules, cosmetics, and chemical products.   read more...   read less

Didier is heading the Knowledge Innovation and Partnership management unit in EFSA. Responsibilities include: Defining EFSA’s scientific outlook through foresight and the scanning of scientific, technologica and societal information, including emerging risk identification. Envisioning EFSA's long-term competency needs. Make EFSA join forces by setting up multilevel partnership frameworks, in line with ecosystem thinking. Developing scientific sourcing solutions and promote capacity building.​​​​​​​Facilitating the management of knowledge and innovation within the EU and globally, including the coordination of cross-cutting scientific knowledge activities. Evolving the risk assessment process by bringing in AI based process automation and engage with society and knowledge communities using crowdsourcing and citizen science.   read more...   read less

Paul Whaley, PhD, is a researcher, consultant, and academic editor, specialising in evidence synthesis methods and open science publishing practices. He has a particular interest in using systematic review and evidence mapping to make sense of research in support of policy goals, and the development and use of data standards for improving the quality of published research and allowing our approaches to storing and analysing scientific evidence to scale with the rate at which it is being produced. Paul is Editor-in-Chief of Evidence-Based Toxicology, a new open science journal for environmental health research. EBT's mission is to support the use of evidence-based methods in toxicology and implement new academic publishing models that lead to a better-functioning research ecosystem.   read more...   read less

Prof. Maurice Whelan is Deputy Director of the Directorate for Health and Food and head of the Systems Toxicology Unit at the European Commission's Joint Research Centre (JRC) based in Ispra, Italy. He also heads the JRC's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM). Maurice is the EU co-chair of the OECD Advisory Group on Emerging Science for Chemicals Assessment (ESCA); a member of the Steering Committee of the European Partnership for Alternative Approaches to Animal Testing (EPAA); and chair of the Regulatory Advisory Board of the European Organ-on-Chip Society (EUROoCS). His publications include over 200 scientific papers and a book on the validation of alternative methods for toxicity testing. He has held a number of external appointments including the 2017-2018 Francqui Chair for alternative methods at the Vrije Universiteit Brussel (VUB, Belgium) and is currently visiting Professor of Bioengineering at the University of Liverpool (UK).   read more...   read less

Dr James Chan graduated with a Bachelor of Pharmacy degree and obtained his doctoral degree in Pharmaceutical Science from the National University of Singapore. Subsequently he joined A*STAR in 2018 and established an independent research group in 2020 in both the Singapore Institute of Food and Biotechnology Innovation (SIFBI), and the A*STAR Skin Research Labs (ASRL). He is currently a Junior Principal Investigator with extensive expertise in physiologically-based pharmacokinetic models. In particular, his team develops in vitro and in silico tools to investigate transporter-mediated pharmacokinetics. His current research interests include the modelling of long half-life environmental PFAS contaminants, prediction of the biokinetics for pharmaceutical, nutritional and consumer care compounds, and modelling sensitive populations such as pregnant mothers and maternal-fetal transfer.   read more...   read less

Dr. Djork-Arné Clevert has a background in computer science and received his doctorate on machine learning for computational biology. In 2022 he accepted a global role as VP, Head of Machine Learning Research within Pfizer Research. Prior to that, he was seven years in pharmaceutical research at Bayer and became Director, Head of Machine Learning Research in 2019. He was a senior scientist in the prestigious Hochreiter Lab at the Institute of Bioinformatics at Johannes Kepler University from 2007 to 2015. He has been Co-PI in several large projects with pharma industry, in particular, transcriptome analysis and statistical genetics with Johnson and Johnson and Merck Serono Geneva, respectively. His research has mainly been concerned with microarray data in earlier years. Later he shifted this research focus to the prediction of biological effects of compounds with methods, such as, deep neural networks. A highlight of his Marie Curie fellowship was the introduction of the Exponential Linear Units (ELUs), which has become a de-facto standard in the field of deep learning. Dr. Clevert is the author of over 60 research articles, scientific reviews, and book chapters with more than 10000 citations in total and released the Open Source software packages FARMS, cn.FARMS, RFN and Img2Mol.   read more...   read less

Dr. Cubadda is Senior Scientist and Team Leader at the Italian National Institute of Health with expertise in analytical sciences, exposure assessment and toxicology. He leads a group with a long track record in research on analytical determination and toxicology of nanomaterials as well as risk assessment of nanotechnology applications. Current interest is mainly in the area of NAMs in nanotoxicology, in which he coordinates international projects (NANOCELLUP, NAMS4NANO Lot 3). Expert in food safety risk assessment, in both the chemical and the nutritional domain, he has been member of several working groups of the European Food Safety Authority (EFSA) and is a current member of the Cross cutting Working Group on Nanotechnology. Author of >180 papers in international journals, he acted as chairman of national and international conferences and as lecturer for different Universities.   read more...   read less

Dr Jean Lou Dorne has been working in EFSA as a Senior Scientific Officer in Toxicology since 2006 and is currently working in the preparedness team of the Methodological and Scientific Support Unit. Previously, he spent 9 years at the University of Southampton between a PhD and 5 years of postdoctoral research UK on “human variability in kinetics and metabolism and refinement of uncertainty factors for chemical risk assessment”. His work focuses on NAMs in chemical risk assessment, toxicology, ecotoxicology including development of a)EFSA’s OpenFoodTox database and associated in silico tools, b) TKPlate 1.0 platform, c) harmonised methods for mixture risk assessment for humans, animals and the environment d)Training programmes in chemical risk assessment in the NAM area.   read more...   read less

Clinical physiologist and PhD in biology with 23 years of experience in drug discovery and drug development. Founder of Inoviem Scientific highly focused on personalised medicine using proprietary technologies and Artificial Intelligence platform to help pharma and biotech companies in develop of their compounds from early discovery to patient. Professor in experimental medicine at University hospital KSMA in Bishkek in connection to Germane higher education.

Dr. Hong Fang is a highly accomplished Senior Health Information Scientist at the US FDA, bringing over 20 years of experience in computational science, data science, chemoinformatics, toxicoinformatics, and bioinformatics to her role. At the FDA, Dr. Fang spearheads bioinformatics research and is responsible for the development of tools that support FDA's health informatics initiatives. A comprehensive list of the currently available software tools and informatics systems can be found on NCTR/FDA webpage: https://www.fda.gov/science-research/bioinformatics-tools. One noteworthy tool is FDALabel, which is hosted on the Amazon Cloud. FDALabel is a web-based application that facilitates full-text search of the FDA's drug labeling documents. It experienced a significant user access rate last year, with 100,000 visits recorded. In addition to her research and project management roles, Dr. Fang is a prolific writer. She has authored and co-authored a remarkable 164 manuscripts, accumulating an impressive 15,900 citations. Her Google Scholar H-Index is 59, highlighting the impact and influence of her scholarly contributions   read more...   read less

Dr. Anil Patri serves as the Director, Nanocore and Chairs FDA’s Nanotechnology Task Force to conduct and coordinate regulatory science research, provide reviewer training, and standards development. He serves on the Nanoscale Science, Engineering, and Technology Subcommittee (NSET) on behalf of FDA. He chairs the Nanotechnology Working Group of the Global Coalition for Regulatory Science Research (GCRSR) to address emerging challenges, consensus development and capacity building. Prior to joining FDA in 2014, Dr. Patri served as the Deputy Director, Nanotechnology Characterization Laboratory at the Frederick National Laboratories for Cancer Research to oversee the clinical translation of nanomedicines. A synthetic organic chemist by training, his graduate research was on dendritic nanomaterial, followed by exploring their potential for cancer targeting, imaging and drug delivery at the University of Michigan.   read more...   read less

Dr. Joshua Xu received his Ph.D. degree in electrical engineering from Texas A&M University with research in medical image analysis. Currently he is the Branch Chief for Research-to-Review and Return (R2R) at the Division of Bioinformatics and Biostatistics of FDA's National Center for Toxicological Research (NCTR). He specializes in bioinformatics, text mining, image analysis, artificial intelligence, and informatics system development. He leads the Division’s efforts in developing regulatory informatics applications and systems. Some ongoing projects are Data Analysis and Search Host (DASH), Breakthrough Therapy Designation (BTD), Safety Policy and Research Team (SPRT), Smart Template System (STS) and FDA drug labeling documents (FDALabel) in collaboration with CDER. The R2R program has also developed a prototype for the Automated Laboratory Information System (ALIS), a customizable system that can be tailored to specific needs across all FDA sample testing laboratories; and created the ASSIST4Tobacco, which uses AI/NLP for deeper searching of documents concerning tobacco products.   read more...   read less